Gan & Lee Pharmaceuticals Initiates Phase I Trial for Once-Weekly Oral GLP-1 Peptide GZC8072 in China, Targeting Obesity and Type 2 Diabetes

September 20, 2026

AllSci China

Overview

Gan & Lee Pharmaceuticals Co., Ltd. has commenced its Phase I clinical trial for GZC8072, a novel once-weekly oral GLP-1 receptor peptide agonist, targeting type 2 diabetes and weight management in overweight or obese individuals. The multi-center, randomized, double-blind, placebo-controlled study will enroll 112 participants across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. This oral peptide represents a significant step towards enhancing patient convenience and adherence in the GLP-1 market, which is currently dominated by injectable formulations.

In Depth

Key Findings

Gan & Lee Pharmaceuticals Co., Ltd., a prominent Chinese pharmaceutical company, has announced the dosing of the first subject in its Phase I clinical trial for GZC8072. This investigational drug is a novel once-weekly oral peptide GLP-1 receptor agonist, designed to address Type 2 Diabetes Mellitus (T2DM) and weight management in individuals who are overweight or obese.

Technical / Clinical Details

The Phase I trial (CTR20263271) is structured as a multi-center, randomized, double-blind, placebo-controlled study with two main components. The first part involves a Single Ascending Dose (SAD) regimen in healthy adult participants, focusing on preliminary safety and pharmacokinetic profiling of GZC8072. The second part, a Multiple Ascending Dose (MAD) study, will enroll overweight or obese subjects to evaluate the drug’s sustained safety, tolerability, and pharmacodynamic effects over a longer period. A total of 112 participants are slated to be enrolled, aiming to comprehensively characterize the initial human profile of GZC8072.

Background & Context

GLP-1 receptor agonists have revolutionized the treatment landscape for T2DM and obesity, offering substantial benefits in glycemic control and weight reduction. However, a major limitation of many existing GLP-1 agonists is their injectable administration, which can pose compliance challenges for patients requiring long-term therapy. The development of a once-weekly oral peptide GLP-1 receptor agonist like GZC8072 represents a significant advancement in drug delivery, promising enhanced patient convenience and potentially higher adherence rates. An oral formulation could significantly broaden patient access to GLP-1 therapies, by mitigating needle-related anxieties and logistical burdens, thereby impacting a broader market segment.

Strategic Significance & Outlook

The successful progression of GZC8072 into Phase I clinical trials marks a crucial step in the pursuit of more patient-friendly diabetes and obesity treatments. Positive outcomes from this study could pave the way for larger-scale clinical development, potentially establishing GZC8072 as a transformative therapeutic option that improves patient quality of life. The combination of once-weekly dosing and oral administration offers a clear competitive advantage over current injectable options, making GZC8072 a highly anticipated candidate in the global metabolic disease market.

Source: https://allsci.com/news/first-in-human-trials/oral-glp-1-peptide-gan-lee-advances-once-weekly/

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